Kornimate/medical-research-clean huggingface dataset:
long term followup of patients enrolled in mc1137, beauty study

Conditions: Breast Carcinoma

Summary: this study gathers information and samples for further analysis as part of the beauty study. the purpose of the beauty study was to better understand the reasons why or why not breast cancers respond to standard chemotherapy. collecting samples of blood and tissue and health and treatment information from patients on the beauty study may help doctors identify changes that make cancer better respond to standard chemotherapy and develop better therapies for the treatment of cancer.

primary objectives: i. evaluate the association of residual cancer burden and breast cancer disease-free interval. ii. evaluate the trajectory of circulating tumor cell (ctc) and circulating tumor-deoxyribonucleic acid (ctdna) over time after breast cancer treatment and the association with breast cancer disease-free interval. iii. evaluate the association of peripheral blood immune phenotype (circulating immune cell subpopulations as measured by cytometry by time-of-flight \[cytof\]) over time with breast cancer disease-free interval. iv. develop and use patient derived xenograft (pdx) models from recurrent breast cancer to identify mechanisms of treatment resistance and to study new drugs/drug combinations. v. evaluate changes in the genomic and proteomic landscape over time, by sequencing recurrent disease and comparing with sequencing data from the primary tumor. vi. assess the spatial immune micro-landscapes of pre-treatment and treated tumors. vii. generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response and immune evasion mechanisms. outline: patients undergo collection of blood samples throughout the study. patients may also complete questionnaires and/or undergo the collection of tissue samples throughout the study.

Eligibility criteria:
inclusion criteria: * registration - for patients still alive: * enrolled in beauty \[mc1137 (nct02022202)\] and did not withdraw consent while enrolled on beauty for either specimen collection or long-term follow-up * able to provide written informed consent * registration - for patients who have died: * enrolled in mc1137 and did not withdraw consent while enrolled on beauty for either specimen collection or long-term follow-up * existence of a family member willing to provide consent for use of archived tumor biopsies obtained after enrollment in beauty
endothelial healing assessment with novel coronary technology

Conditions: Coronary Artery Disease

Summary: this is a prospective, non-randomized, single center clinical trial to assess neointimal coverage on the stent or scaffold strut and apposition of synergy™ and absorb in minimum of 12 eligible human subject at 4 month and 12 month after stent or scaffold implantation using oct and cas

all of the subject will received synergy™ stent in one of the blocked coronary artery and absorb scaffold strut in the other artery. all subjects must have 2 coronary arteries stenosis of more than 70%.

Eligibility criteria:
inclusion criteria: 1. subject is 20 years old or older 2. subject or legally authorized representative must provide written informed consent prior to any study related procedure, per site requirements. 3. subject must have evidence of myocardial ischemia (eg stable or unstable angina, silent ischemia) suitable for elective pci 4. significant narrowing of at least 70% stenosis of de novo lesion (qca or visual estimation) in 2 different native coronary arteries. 5. subject is eligible for to undergo oct and cas examination at 4 months and 12 months after stent or scaffold implantation. 6. subject is able to take dual anti-platelet therapy up to one year following the index procedure and anticoagulants prior/during the index procedure exclusion criteria: 1. subject had an acute myocardial infarction (stemi or nstemi) within 24 hours of the index procedure 2. subject has known left ventricular ejection fraction (lvef) \< 30% 3. subject is receiving hemodialysis 4. target vessel were treated by pci within 12 months 5. target lesion is located within a saphenous vein graft or an arterial graft 6. target lesion is located in ostium 7. target lesion is located highly tortuous equal to or greater than 60 degrees 8. target lesion with timi flow 0 (total occlusion)

Keywords: synergy neointimal formation oct coronary angioscopy coronary artery disease
bioequivalence study of torrent pharmaceuticals ltd's bioequivalence study of torrent pharmaceuticals ltd's quetiapine tablets under fed conditions

Conditions: Healthy

Summary: objective: primary objective of the present study was to compare the single dose bioequivalence of torrent's quetiapine fumarate tablets 1 × 25 mg. dosing periods of the study were separated by a washout period of 7 days. study design: open label, randomized, two-way, crossover, single-dose bioequivalence study


Eligibility criteria:
inclusion criteria: the volunteers were included in the study based on the following criteria: * sex: male. * age: 18 - 45 years. * volunteer with bmi of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight. * healthy and willing to participate in the study. * volunteer willing to adhere to the protocol requirements and to provide written informed consent. * non-smokers or smoker who smokes less than 10 cigarettes per day exclusion criteria: the volunteers were excluded from the study based on the following criteria: * clinically relevant abnormalities in the results of the laboratory screening evaluation. * clinically significant abnormal ecg or chest x-ray. * systolic blood pressure less than 100 mm hg or more than 140 mm hg and diastolic blood pressure less than 60 mm hg or more than 90 mm hg. * pulse rate less than 50/minute or more than 100/minute. * oral temperature less than 95°p or more than 98.6°p. * respiratory rate less than 12/minute or more than 20/minute * history of allergy to the test drug or any drug chemically similar to the drug under investigation. * history of alcohol or drug abuse * positive breath alcohol test * recent history of kidney or liver dysfunction. * history of consumption of prescribed medication since last 14 days or otc medication since last 07 days before beginning of the study. * volunteers suffering from any chronic illness such as arthritis, asthma etc. * history of heart failure. * hiv, hcv, hbsag positive volunteers. * opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - cocaine positive volunteers based on urine test. * volunteers suffering from any psychiatric (acute or chronic) illness requiring medications. * administration of any study drug in the period 0 to 3 months before entry to the study. * history of significant blood loss due to any reason, including blood donation in the past 3 months. * history of pre-existing bleeding disorder. * existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers. * inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
the analgesic effect of qlb ii after robotic prostatectomy. (qlb ii: quadratus lomborum block ii type)

Conditions: Postoperative Pain

Summary: the analgesic effects of quadratus lomborum block ii type after robotic-assisted laparoscopic radical prostatectomy, will be assessed.

quadratus lomborum block ii type will be performed before performing robotic-assisted laparoscopic radical prostatectomy. the post-operative analgesic effect will be assessed, by using numeric rate scale for pain. the pain assessment will be evaluated during the first 24 hours from surgery. the opioids requirement and side effects will be also assessed.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist status i-iii * written informed consent exclusion criteria: * body mass index \> 35 kg/m2 * allergies to local anesthetics * primaries or secondaries coagulopathies * addiction to drugs * severe kidney and liver diseases * cognitive impairment

Keywords: pain, radical prostatectomy, qlb ii type
long-term efficacy, safety and tolerability of pramipexole in patients with idiopathic moderate to severe restless legs syndrome (rls)

Conditions: Restless Legs Syndrome

Summary: the primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe restless legs syndrome (rls) in comparison to placebo. the key secondary objectives are to assess the effects on clinical global impressions - global improvement (cgi-i) (based on cgi-i responder rate) and on rls (based on irls responder rate) for 26 weeks under pramipexole in comparison to placebo. further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (pgi) (based on pgi responder rate), on rls symptoms (based on the rls-6 scales), on associated mood disturbance (based on item 10 of the irls), on pain in limbs (based on a visual analogue scale (vas)), on quality of life in rls (based on johns hopkins rls-qol), on general quality of life short form 36 (sf-36) and on safety (based on adverse events (ae) profile) of pramipexole in comparison to placebo.


Eligibility criteria:
inclusion criteria: 1. written informed consent consistent with international conference on harmonization - good clinical practice (ich-gcp) and local institutional review board/independent ethics committee (irb/iec) requirements obtained prior to any study procedures being performed and the ability and willingness to comply with study treatment regimen and to attend study assessments 2. male or female out-patients aged 18-85 years 3. diagnosis of idiopathic rls according to the clinical rls criteria of the international restless legs syndrome study group (irlssg) \[p03-03355\]. all four criteria must be present to fulfil the diagnosis of rls. 4. rls symptoms present at least 2 to 3 days per week during the last 3 months prior to baseline (visit 2) 5. irls total score \>15 at baseline (visit 2) exclusion criteria: 1. women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 6 months after last menses) who do not use during the clinical trial an adequate method of contraception such as: double barrier protection (e.g. diaphragm or condom and spermicide), intrauterine device, hormonal therapy (oral, injectable, or subcutaneous), or partner's surgical sterilization 2. any woman of child-bearing potential not having a negative pregnancy test at screening 3. breastfeeding women 4. patients with known hypersensitivity to pramipexole or any other component of the investigational product or placebo tablets 5. diagnosis of augmentation under previous pharmacological rls treatment 6. concomitant or previous pharmacologic therapy as follows: any intake of dopamine agonists within 14 days prior to baseline (visit 2); any intake of levodopa within 14 days prior to baseline (visit 2); unsuccessful prior treatment with non-ergot dopamine agonists (e.g. pramipexole, ropinirole);
ankle injuries, imaging and prevention program effectiveness in new army recruits

Conditions: Ankle Sprains

Summary: infantry recruits will undergo a musculoskeletal examination to assess tendon, muscle, proprioception, agility, and joint status. afterward, an exercise intervention program will be implemented, followed by a concluding evaluation.

purpose: to evaluate ankle injuries in new infantry recruits, including their characteristics, association with imaging and functional measures, and the effectiveness of a preventive exercise program. methods: 650 new male infantry soldiers aged 18-23 will be recruited to participate in the study at the beginning of their military training. at the beginning and the end of the training (after approximately six months), the soldiers will be assessed for the following: 1. demographics (height, weight, leg length, bmi calculation), 2. proprioception ability (active movement extent discrimination apparatus ameda), 3. dynamic balance (y-balance test ybt), 4. leg muscle strength (bilateral heel rise test), 5. hip strength (hand-held dynamometer), 6. ankle agility (hexagon agility hop test), 7. ankle stability (anterior drawer test, musculoskeletal ultrasound for the anterior talofibular ligament), 8. achilles tendon structure (ultrasound tissue characterization utc), 9. aerobic ability (3000 meters run, will be recorded by the fitness instructors at the training base). in addition, the soldiers will fill out a previous ankle sprains questionnaire, pre-induction physical activity questionnaire, the cumberland ankle instability tool (cait) for ankle perceived instability, and the ankle fear avoidance beliefs questionnaire (ankle-fabq). the soldiers will perform a constructed ankle sprain prevention program for five minutes every day during the six-month length of the study. every 1-2 weeks, the researcher will arrive at the training base to monitor ankle injuries. those who are diagnosed with a sprain will undergo ultrasound evaluations, which will be performed every few weeks.

Eligibility criteria:
inclusion criteria: * soldiers ages 18-22 exclusion criteria: * knows disease of the bones * before orthopedic surgery

Keywords: soldiers injury ankle exercise
opioid-free anesthesia in thoracic surgery

Conditions: Thoracic; Surgery

Summary: no study has been conducted to demonstrate the feasibility and safety of an opioid-free anesthesia (ofa) protocol compared to opioid-based anesthesia (oba) in thoracic surgery, at risk for intense post-operative pain, to improve patient care. the aim of the present study was to evaluate the effect of ofa on post-operative opioids consumption, pain and the post-operative period after lobectomy by video-assisted thoracoscopy surgery (vats). systems. investigators perform a retrospective, single-center study in 2019. patients were divided into two groups: ofa (with dexmedetomidine) or oba (sufentanyl). investigators analyse the total postoperative opioid consumption in the 48 h after surgery. investigators asses pain intensity in the 48 h after surgery, operative hemodynamic stability, post-operative pain (pop) in post-anesthesia care unit (pacu) and pop on day 30. all data are available in the medical record hypothesis: ofa can reduce post-operative opioids consumption, pain in lobectomy by video-assisted thoracoscopy surgery (vats).


Eligibility criteria:
inclusion criteria: * all consecutive patients admitted for lobectomy or wedge video-assisted thoracoscopy * opioid free anesthesia (ofa) administration was left to the discretion of the attending anesthetist according to his or her practices and habits. * age 18 or over * lobectomy or wedge resection by video-assisted thoracoscopy surgery (vats) exclusion criteria: * toxicomania, * epidural analgesia use, * thoracotomy conversion * patient-controlled analgesia with morphine (pca) * patient who object to take part of the study.

Keywords: post-operative pain
using a new human milk fortifier to optimize feeding

Conditions: Preterm Infant; Growth

Summary: this study aims to compare the safety and efficacy of a new hmf and those of other hmf used before in very preterm infants.

infants with fortified human milk feeding have the same rate of growth, lower incidence of nosocomial infections and feeding intolerance compared to those with formula feeding during hospitalization. however, the currently human milk fortifiers (hmf) have some nutritional components defects to meet the needs of very preterm infants. new hmf provide higher protein and fat, which are safe and well tolerate to use in preterm infants. study on safety and efficacy of the new hmf is insufficient in chinese preterm infant population. our aims are to compare the safety and efficacy of a new hmf and other hmf used before in very preterm infants. very low preterm infants with birth weights of 1000-1499g and gestational age 28+0 weeks to 31 + 6 weeks are included. infants feeding with new hmf are in the experimental group. infants feeding with other hmf are in the control group, a historically control group. physical growth, nutritional indexes, incidence of feeding intolerance, and time to achieve full enteral feeding are compared between the two groups.

Eligibility criteria:
inclusion criteria: * infants with gestational age between 28+0 weeks to 31+6 weeks, and 1000g≤ birth weight\<1500g; * delivered in the study centers or transfer to the study centers within 24 hours after birth; * own mother's milk or human milk bank were available; * only one of the twins is selected in this study; * informed consent has been obtained. exclusion criteria: * severe congenital malformations, severe asphyxia, intracranial hemorrhage and other diseases; * small for gestational age infants (birth weight below the 10th percentile of the reference, fenton premature infant growth chart (2013)）; * enteral feeding is not tolerated in 14 days after birth; * infants who have participated in other clinical trials within 1 month; * other conditions not suitable for this study.
biomarkers in predicting response to chemotherapy in patients with advanced or metastatic melanoma previously treated with carboplatin and paclitaxel with or without sorafenib tosylate

Conditions: Melanoma (Skin)

Summary: rationale: studying samples of tissue in the laboratory from patients receiving carboplatin and paclitaxel with or without sorafenib tosylate may help doctors learn more about the effects of this treatment on cells. it may also help doctors understand how well patients respond to treatment. purpose: this research study is studying biomarkers in predicting response to chemotherapy in patients with advanced or metastatic melanoma previously treated with carboplatin and paclitaxel with or without sorafenib tosylate.

objectives: * to independently correlate the gene expression and promoter methylation profiles to chemotherapy response in patients with advanced or metastatic melanoma treated with carboplatin and paclitaxel with versus without sorafenib on clinical trial ecog-e2603. * to develop a predictive model of chemotherapy response utilizing integrated analysis of gene expression and promoter methylation data. * to evaluate whether the ner pathway haplotypes are associated with platinum drug resistance and survival. outline: this is a multicenter study. archived paraffin-embedded tissue samples are analyzed for gene expression and promoter methylation profiles, and genes involved in the ner pathway.

Eligibility criteria:
disease characteristics: * diagnosis of melanoma * unresectable locally advanced or stage iv disease * received carboplatin and paclitaxel with versus without sorafenib on clinical trial ecog-e2603 * archived paraffin-embedded tissue samples * responder (complete or partial response, or stable disease) and non-responder (disease progression or unavailable) patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent melanoma stage iiic melanoma stage iv melanoma
benefit of a single preoperative dose of antibiotics for the prevention of surgical site infections

Conditions: Surgical Site Infection

Summary: in a rural hospital in tanzania the rate of surgical site infections (ssi) was 21.6%. inappropriate choice of antibiotics and of administration time were determined as sole risk factors in this setting. after implementation of a standardized procedure with a single shot dose of amoxicillin/clavulanic acid approximately 30 min. preoperatively the rate of ssi dropped by 80% in spite of procedural risk factors like poor hygiene etc.

surgical site infections (ssis) have an important socioeconomic impact prolonging the period of hospitalization and rehabilitation. patients with ssis are five times more likely to be readmitted and are even twice as likely to die compared to patients with similar interventions without ssi. in non-industrialized countries, the incidence of ssis is higher and the consequences of ssi are even more severe: many hospitals lack appropriate facilities for early diagnosis and treatment. in addition, microbiological identification of pathogens and susceptibility testing are rarely available, a prerequisite for targeted treatment of ssis. overcrowding and understaffing are additional risk factors for ssis, common in these countries. a study conducted at the local surgeons' suggestion in an 82-bed department of general surgery, obstetrics and gynecology, urology and orthopedics at the st. francis designated district hospital (sfddh) in ifakara (southern tanzania) showed an ssi-rate of 21.6%. the analyses of this study identified two major risk factors for ssi in clean and clean-contaminated surgical procedures: inadequate timing of administration of routine antimicrobial prophylaxis (amp) and inappropriate selection of antibiotics not covering the most commonly observed pathogens. therefore, an intervention study was discussed with the local surgeon in charge to improve selection and timing of routine amp and thereby reduce the rate of ssis. the study design and objective were presented to all the staff during a general meeting and special duties and responsibilities discussed with the individual colleagues. furthermore we distributed pocket flow sheets to the involved staff and hung up some laminated flow sheets in theatre.

Eligibility criteria:
inclusion criteria: * surgical patient * clean or clean-contaminated surgery exclusion criteria: * infection * preoperative antibiotic treatment * postoperative antibiotic treatment * open fractures

Keywords: postoperative wound infection surgical site infection antimicrobial prophylaxis developing countries sub-saharan africa reduction of ssi using preoperative antibiotics